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Comparison of Transanal Irrigation and Glycerol Suppositories in Treatment of Low Anterior Resection Syndrome: A Multicentre Randomised Controlled Trial
The study is a multicentre randomized controlled trial with the objective to compare the effect of transanal irrigation with glycerol suppositories in patients suffering from major Low Anterior Resection Syndrome (LARS).
Details
| Lead sponsor | University of Aarhus |
|---|---|
| Phase | Phase 3 |
| Status | RECRUITING |
| Enrolment | 114 |
| Start date | 2019-09-17 |
| Completion | 2026-12 |
Conditions
- Low Anterior Resection Syndrome
- Rectal Cancer
Interventions
- Qufora Irrisedo Cone System
- Glycerol "OBA"
Primary outcomes
- Bowel function, change in symptom 1 score assessed using the Measure Yourself Medical Outcome Profile (MYMOP2) Score. — 12 weeks.
MYMOP2 is a validated problem-specific, patient-generated questionnaire. Patients are asked to specify one or two symptoms that concern them the most. Subsequently they evaluate the severity on a 7-point Likert scale. The second part of the questionnaire uses the same scale to assess whether the symptom limits or prevent any daily activity, and also to rate general well-being. Follow-up questionnaires address the original issues completed in the initial form. Symptom 1, symptom 2, activity, and wellbeing each have a separate score between 0 and 6 with 0 indicating "as good as it could be" and 6 "as bad as it could be". An overall score is calculated by taking the average of item scores.
Countries
Denmark